BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3980082 · Received July 2, 2014

    Report

    Report Number
    1720753-2014-05645
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE AND HARD DISK DRIVE WERE EVALUATED AND REPLACED. THE SYS SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED DURING THE SERVICE EVENT. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS INTERMITTENTLY FAILED TO PROPERLY SAVE AND RECALL PT IMAGE DATA. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388778 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1